Cleared Traditional

K890428 - DELFIA PROGESTERONE KIT

K890428 is an FDA 510(k) clearance for DELFIA PROGESTERONE KIT, manufactured by Pharmacia, Inc.. The device is a Class 1 Chemistry device with product code JLS cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K890428 · Pharmacia, Inc. · Chemistry device
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Feb 1989
Decision
28d
Days
Class 1
Risk

K890428 is an FDA 510(k) clearance for the DELFIA PROGESTERONE KIT. Classified as Radioimmunoassay, Progesterone (product code JLS), Class I - General Controls.

Submitted by Pharmacia, Inc. (Piscataway, US). The FDA issued a Cleared decision on February 23, 1989 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1620 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Pharmacia, Inc. devices

FDA 510(k) Submission Details - K890428

510(k) Number K890428 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 26, 1989
Decision Date February 23, 1989
Days to Decision 28 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 88d · This submission: 28d
Pathway characteristics
Predicate-based equivalence.

JLS Device Classification - Class 1, General Controls

Product Code JLS Radioimmunoassay, Progesterone
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1620
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - JLS Radioimmunoassay, Progesterone

All 40
Devices cleared under the same product code (JLS) and FDA review panel - the closest regulatory comparables to K890428.
SRI PROGESTERONE ENZYME IMMUNOASSAY(MAG SOLD PHAS)
K914462 · Serono-Baker Diagnostics, Inc. · Oct 1991
MILENIA PROGESTERONE
K911512 · Diagnostic Products Corp. · May 1991
ENZYMUN-TEST PROGESTERONE
K910683 · Boehringer Mannheim Corp. · Apr 1991
PROGESTERONE SEROZYME IMMUNOENZYMETRIC ASSAY
K884794 · Serono-Baker Diagnostics, Inc. · Feb 1989
AMERLITE PROGESTERONE ASSAY, LAN.0079/2079 240/144
K884100 · Amersham Corp. · Nov 1988
MODIFIED AMERLEX-M PROGESTERONE RADIOIMMUNO. KIT
K880934 · Amersham Corp. · Apr 1988